CN104364573A

CN104364573A - Aseptic coupling devices

Info

Publication number: CN104364573A
Application number: CN201380027839.8A
Authority: CN
Inventors: 兰德尔·斯科特·威廉斯; 洛伊·特鲁昂格; 布莱尔·普莱克纳; 杰里米·亨利·尼克尔斯
Original assignee: Colder Products Co
Current assignee: Colder Products Co
Priority date: 2012-04-27
Filing date: 2013-03-14
Publication date: 2015-02-18
Anticipated expiration: 2033-03-14
Also published as: US20130289517A1; US20190240474A1; US20220305249A1; US9364653B2; CN107255198B; EP2841838A1; US20160243348A1; US10307583B2; EP2841838B1; IN2014DN09855A; CN107255198A; US11357963B2; WO2013162743A1; CN104364573B

Abstract

An aseptic coupling arrangement (50) including a first coupling device (100a) and a second aseptic coupling device (100b) is disclosed. The first and second coupling devices are substantially similar, each having a main body (102) defining a front face and a fluid passageway (108) therethrough. A first connecting feature disposed on the main body of each coupling device (100a, 100b) may be provided for aligning and coupling the aseptic devices together. Each coupling device may also include a sealing member received in the main body (102) and a membrane (400) removably coupled to the main body front face to cover the sealing member. The first aseptic coupling device may also include a rotatable protective cover (300) that is removably attached to the main body (102) and connected to the membrane (400). The removal of the protective covers (300) away from two coupled main bodies (102), in a direction parallel to the front faces, causes removal of the membranes (400).

Description

Sterility coupling gear

The application submits on March 14th, 2013 as pct international patent application, and the U.S. Provisional Patent Application requiring on April 27th, 2012 to submit to number 61/639, the U.S. Patent Application No. 13/800 that on March 13rd, 121 and 2013 submits to, the preference of 630, the disclosure content of these U.S. Provisional Patent Application is combined in this accordingly by quoting in full with it.

Background

Sterility coupling gear may be used for connecting two or more sterilized fluid passages.Such as, on the fluid passage that sterility coupling gear may be used for making a fluid passage from the first workpiece of processing equipment or container to be attached to from the second workpiece of processing equipment or container, to set up one for carrying out the aseptic path of fluid conveying betwixt.Typical aseptic coupling gear requires one " doing " or " involvement connects " of using the one or more path clamp devices being placed on sterility coupling gear upstream to be formed, when making like this to form connection between sterility coupling gear, sterility coupling gear keeps without fluid.Once form aseptic connection between sterility coupling gear, just clamp device is removed to allow fluid to flow through sterility coupling gear.

General introduction

This disclosure relates to sterility coupling gear and sterility connection arranges.According to this disclosure, disclose an a kind of first sterility coupling gear for being attached on a second sterility coupling gear.In one embodiment, this first sterility coupling gear has first main body, this first main part limitation front and through one of them first fluid passage.Can provide first connection features be arranged in main body, this first connection features is constructed such that the first aseptic device is attached on the second sterility coupling gear.This first sterility coupling gear can also comprise on first sealing component be received at least partly in the first main body and the front being removably attached to the first main body to cover a first film of the first sealing component.

This first sterility coupling gear can also comprise and being removably connected in main body and first protective covers be connected on the first film.This first protective covers can be configured to be rotatable to an open position from a closed position; in this closed position, at least partially, the film in front main body covered in this open position is exposed in the main body covered front of protective covers cover film.In one embodiment, the removal of the first protective covers away from main body on the direction being parallel to front causes the first film to be removed by from front.

Also disclose a sterility connection to arrange, this sterility connection arrangement comprises the first sterility coupling gear and the second sterility coupling gear, and wherein this second sterility coupling gear has with previous for feature identical described in this first sterility coupling gear.Such as, the second sterility coupling gear can comprise second main body, second connection features, the second sealing component, second film and second protective covers.In one embodiment; these protective covers of each device are configured to be attached to one another, and make the film of the first sterility coupling gear and the second sterility coupling gear can be remove from the front of their correspondences in mode that is synchronous or near-synchronous so simultaneously.

In one embodiment, first connection features and the second connection features comprise first link and second link separately, wherein the second link of the first sterility coupling gear can be received in the first link of the second sterility coupling gear, and wherein the second link of the second sterility coupling gear can be received in the first link of the first sterility coupling gear.In one embodiment, the first connector element of the first sterility coupling gear and the second sterility coupling gear and the second connector element are constructed such that the front alignment of each main body, make these fronts be parallel to each other like this.In one embodiment, this first sterility coupling gear and this second sterility coupling gear have a kind of substantially similar structure.

Also disclose a kind of method for the formation of an aseptic connection.A step comprises provides the first sterility coupling gear and the second sterility coupling gear, and wherein this first sterility coupling gear has substantially similar with this second sterility coupling gear one and constructs.The method can also comprise the following steps: a protective covers of the first sterility coupling gear is rotated to an open position to expose a film in a front of covering first sterility coupling gear; And a protective covers of the second sterility coupling gear is rotated to an open position to expose a film in a front of covering second sterility coupling gear.Step other in the method the first sterility coupling gear is connected on the second sterility coupling gear and the protective covers of the first sterility coupling gear is connected in the protective covers of the second sterility coupling gear.Last step in the method can be that the protective covers by making these connect departs to come the front removing films from the first coupling gear and the second coupling gear from the first coupling gear and the second coupling gear on the direction in front being parallel to each main body.Once these films are removed in this way, just provide a sterile fluid path through the first coupling gear and the second coupling gear.

Accompanying drawing explanation

Describe non-limiting and non-exhaustive embodiments with reference to the following drawings, accompanying drawing is not drawn in proportion, and wherein unless otherwise indicated, otherwise in all of the figs, similar reference number refers to similar part.

Fig. 1 is the schematic diagram of an example system of the sterility coupling gear comprising the first workpiece of processing equipment and second workpiece and form aseptic connection betwixt.

Fig. 2 is the perspective view that an exemplary sterility connection arranges when being in a kind of pre-connection state.

Fig. 3 is the side view that the sterility connection of Fig. 2 arranges.

Fig. 4 is the side cross-sectional view that the sterility connection of Fig. 2 arranges.

Fig. 4 A is the schematic side elevation of the film that the sterility connection being applicable to Fig. 2 arranges.

Fig. 4 B is the schematic side elevation that the sterility connection of Fig. 2 arranges, and wherein multiple cover member portion is removed by the main body arranged from connection.

Fig. 5 is that the sterility connection of Fig. 2 arranges to be in a kind of cross sectional view when connecting state.

Fig. 6 is that the sterility connection of Fig. 2 arranges to be in a kind of perspective view when not connecting state.

Fig. 7 is a main body of a coupling gear and the perspective view of protective covers of the sterility connection arrangement of Fig. 2, and wherein protective covers is in an open position.

Fig. 8 is the main body of the coupling gear of Fig. 7 and the rear view of protective covers, and wherein protective covers is in an open position.

Fig. 9 is the main body of the coupling gear of Fig. 7 and the perspective view of protective covers, and wherein protective covers is in a closed position.

Figure 10 is the main body of the coupling gear of Fig. 7 and the first side view of protective covers, and wherein protective covers is in a closed position.

Figure 11 is the main body of the coupling gear of Fig. 7 and the first side view of protective covers, and wherein protective covers is in an open position.

Figure 12 is the main body of the coupling gear of Fig. 7 and the second side view of protective covers, and wherein protective covers is in a closed position.

Figure 13 is the main body of the coupling gear of Fig. 7 and the second side view of protective covers, and wherein protective covers is in an open position.

Figure 14 is the main body of the coupling gear of Fig. 7 and the front view of protective covers, and wherein protective covers is in a closed position.

Figure 15 is the main body of the coupling gear of Fig. 7 and the rear view of protective covers, and wherein protective covers is in a closed position.

Figure 16 is the main body of the coupling gear of Fig. 7 and the front view of protective covers, and wherein protective covers is in an open position.

Figure 17 is the main body of the coupling gear of Fig. 7 and the rear view of protective covers, and wherein protective covers is in an open position.

Figure 18 is the main body of the coupling gear of Fig. 7 and the first side cross-sectional view of protective covers, and wherein protective covers is in a closed position.

Figure 19 is the main body of the coupling gear of Fig. 7 and the first side cross-sectional view of protective covers, and wherein protective covers is in an open position.

Figure 20 is the main body of the coupling gear of Fig. 7 and the second side cross-sectional view of protective covers, and wherein protective covers is in a closed position.

Figure 21 is the main body of the coupling gear of Fig. 7 and the second side cross-sectional view of protective covers, and wherein protective covers is in an open position.

Figure 22 is the main body of the coupling gear of Fig. 7 and the top view of protective covers, and wherein protective covers is in an open position.

Figure 23 is the main body of the coupling gear of Fig. 7 and the bottom view of protective covers, and wherein protective covers is in an open position.

Figure 24 is the perspective view of the main body shown in Fig. 7.

Figure 25 is the front view of the main body shown in Fig. 7.

Figure 25 A is the cross sectional view of a part of the main body of the Fig. 7 intercepted along the section line 25A-25A shown in Figure 25.

Figure 26 is the side cross-sectional view of the main body shown in Fig. 7.

Figure 27 is the perspective view of the protective covers shown in Fig. 7.

Figure 28 is the rear view of the protective covers shown in Fig. 7.

Figure 29 is the side view of the protective covers shown in Fig. 7.

Figure 30 is the front view of the protective covers shown in Fig. 7.

Figure 31 is the perspective view of a sealing component that can be received in the main body shown in Fig. 7.

Figure 32 is the front view of the sealing component shown in Figure 31.

Figure 33 is the side view of the sealing component shown in Figure 31.

Figure 34 is the side cross-sectional view of the sealing component shown in Figure 31.

Figure 35 is the side view of second embodiment of the main body being applicable to the coupling gear shown in Fig. 7.

Figure 36 is the side view of the 3rd embodiment of the main body being applicable to the coupling gear shown in Fig. 7.

Figure 37 is the side view of the 4th embodiment of the main body being applicable to the coupling gear shown in Fig. 7.

Figure 38 is the main body of the coupling gear of Fig. 7 and the first side view of protective covers, and wherein protective covers is in an open position, and wherein main body comprises an optional visual detector further.

Figure 38 A is the side view of the amplification of the coupling gear shown in Figure 38 and visual detector.

Figure 39 is that the sterility formed by two of having in the coupling gear of optional visual detector of Fig. 7 connects the perspective view arranged.

Figure 40 is the side view that the connection shown in Figure 39 arranges.

Figure 41 is the flow chart of a kind of method of the sterility connection of formation first coupling gear and second coupling gear.

Describe in detail

Describe different embodiment with reference to the accompanying drawings in detail, wherein in some views, similar reference number represents similar part and assembly.Mentioning and the scope of unrestricted following claims different embodiment.In addition, any example as set forth in the specification be not intended to be restrictive but only set forth some in much possible embodiment for following claims.

As used herein, term " sterilizing " means in specified degree, make certain surface or volume avoid the process of microorganism.In the exemplary embodiment, one or more sterilization technologies can be used to realize the sterility of different parts, these sterilization technologies comprise gamma radiation, E-electron beam, ethylene oxide (EtO) and/or autoclave technology.

As used herein, term " sterility " refers to any process of maintenance sterilized surface or volume.

As used herein, term " fluid " means any material that can flow, and includes but not limited to liquid, gas, particle or powdery solid, the mixture of two or more fluids or emulsion, the suspension etc. of solid in liquid or gas.

Referring now to Fig. 1, an example system 10 is shown.System 10 comprises first workpiece of processing equipment 20 and a second workpiece of processing equipment 30.In the exemplary embodiment, equipment 20 and 30 is the bioreactors comprising biomaterial.In other embodiments, equipment 20 and 30 can be other equipment requiring an aseptic connection therebetween, such as, as a bioreactor and a medium bag or other containers.

Equipment 20 comprises a fluid passage 22 from wherein extending, and this fluid passage connects arrangement 50 by the sterility comprising a first sterility coupling gear 100a and stops.Equally, equipment 30 comprises a fluid passage 32 from wherein extending, and the second sterility coupling gear 100b that this fluid passage connects arrangement 50 by this sterility stops.In the exemplary embodiment, sterility coupling gear 100a and 100b is substantially similar (such as, identical, except likely different in termination).In the exemplary embodiment, the environment in path 22 and 32 and sterility coupling gear 100a and 100a is aseptic.

Sterility connection arrangement 50 one can not connect state, a kind of pre-connection state and the placement of a kind of connection state.Fig. 6 illustrates and is in a kind of sterility connection arrangement 50 not connecting state, and wherein coupling gear 100a, 100b is alignment, but is connected to each other not yet by any way.Under pre-connection state, as shown in Fig. 2 to Fig. 4, these devices 100a, 100b are connected to each other, but be sealed to through their fluid passage coupling gear 100a, 100b each on a film 400 block.Under connection state, as shown in Figure 5, film 400 is removed and between equipment 20 and equipment 30, sets up a sterile fluid path.Once sterile fluid path is established, just fluid can be transported to equipment 30 from equipment 20, vice versa.

In example shown embodiment, sterility coupling gear 100a and 100b has similar structure.Like this, coupling gear 100a and 100b can be called separately coupling gear 100, so that reference at this.But should point out, each sterility coupling gear 100a, 100b all can be equipped with the feature different from another sterility coupling gear as required.

As illustrated with a kind of state assembled completely in Fig. 7 to Figure 23, coupling gear 100 comprises a main body 102, the sealing component 200 be arranged in this main body 102.Coupling gear 100 also comprises the protective covers 300 be removably connected in main body 102.Cover piece 300 is rotatable between a closed position (such as, referring to Fig. 9) Yu an open position (such as, referring to Fig. 2) relative to main body 102.A film 400 is also arranged on coupling gear 100, and this film is removably connected at first end 402 place in main body 102 and at second end 404 place and is connected in protective covers 300.Each in these features that coupling gear 100 is hereafter described in further detail.

As the most easily observed in Figure 24 to Figure 26, main body 102 has a front 104 and 106 below, is formed with a tubes connection 108 on after this.A fluid passage 110 in main body 102 is limited between first open end 112 and second open end 114.As the most easily seen in fig. 26, main body 102 limits a recess 116, and this recess has a first internal diameter D.sub.1, for receiving a sealing component 200, as described below.Tubes connection 108 limits a second internal diameter D.sub.2 along fluid passage 110.There is provided Second bobbin diameter D.sub.2 with a size, this size is almost identical with the nominal inside diameter of this conduit generally, and main body 102 is designed to be connected on this conduit.Such as, D.sub.2 can be designed to the stream providing 1/4 inch diameter.In the position that the first internal diameter D.sub.1 and the second internal diameter D.sub.2 adjoins, so that from front, 104 1 degree of depth L.sub.1 form a sealing seat 118, for being supported by sealing component 200 and forming a sealing.

As previously mentioned, the second end 114 of fluid passage 110 is configured to be connected on a fluid passage by tubes connection 108.In the example shown, this tubes connection is that band barb is to form a kind of connection of HB type, make main body 102 can be connected to a fluid passage (such as like this, 22) on, as having a pipe or the flexible pipe of specified diameter (such as, 1/8 inch, 1/4 inch and 3/8 inch).Other large-sizes are also possible, such as 1/2 inch, 5/8 inch, 3/4 inch, 1 inch etc.In embodiment shown in Fig. 2 to Figure 26, for the connection of 1/4 inch, size is determined to tubes connection 108.Figure 35 illustrates and is arranged on the tubes connection 108 ' that a main body 102 ' is upper, determine size for the connection of 1/8 inch.Replace the connection features of a band barb, the connection of a lot of other types as known in the art can be provided, such as, the connection of the connection of bathroom type, the connection of loudspeaker type, the connection of thread type, the connection of quick connect type and compression type.In order to further illustrate these options, Figure 36 illustrates and is arranged at a main body 102 " on a bathroom tubes connection 108 ", and Figure 37 illustrates and is arranged at a main body 102 " ' on the tubes connection 108 of a quick connect type " '.Tubes connection 108 can also be set to a female and connect.In other instances, this connection can be a quick connect type body with a lock bolt and valve.This allows this body to be attached to be mounted on a positive inserting member of conduit in process fluid flow.When completing, this positive inserting member causes valve to be closed from the removal quick connect type body, forms a valve thus and disconnects.

Still with reference to Figure 24 to Figure 26, the front 104 of main body 102 comprises multiple bearing protuberance (stand-off protrusion) 124 further, and these bearing protuberances are configured to the corresponding multiple bearing protuberances 124 engaged under certain conditions on the front 104 of another main body 102.Such as, at least some in relative seat protuberance 124 is by when main body 102 is overly compressed together and/or contacting one another when a side load is applied on one or two of main body 102.In pre-coupled position and coupled position, when there is no external force, opposing projections 124 is general not contacting one another, thus allows Sealing 200 because of the link 132,134 (as mentioned below) in main body 102 and engage completely each other and mutual compression is abutted together.Like this, bearing protuberance 124 contributes to stablizing this connection, to reduce the possibility of the leakage of side load induction.Those of ordinary skill in the art have learned will understand during concept disclosed by this presents, and more or less bearing protuberance can be provided on each face same described functional to guarantee.

The front 104 of main body 102 can be provided with surface location 120,122, is attached on front 104 to allow the first end 402 of film 400.In instances, film 400 is attached on front 104 around with first open end 112 of crossing main body 102 completely at attachment location 120,122 place.Attachment location 120,122 permission film 104 extends across the opening in open end 112, and make like this when film 400 is removed, the sterility of open end 112 is maintained.In one embodiment, these surface locations 120,122 are provided with a kind of tackiness agent 148, and film 400 is attached on this tackiness agent in a kind of folded arrangement, as schematically shown in Fig. 4 A.In one embodiment, tackiness agent 148 can be provided on film 400, and this film can be attached on surface location 120,122 subsequently.In one embodiment, film 400 is thermally welded on front 104.In such an embodiment, surface location 120,122 may not be required.

As shown in the figure, main body 102 is also provided with a recess 126, and this recess is used for engaging to the corresponding lock bolt 306 of in protective covers 300 when protective covers 300 is rotated in closed position.Other arrangements for making protective covers 300 remain in closed position are also possible.Such as, can a lock bolt be set in main body 102 and can a recess be set in protective covers 300.

Main body 102 is also provided with a pair hinge member 128,130, remains on protective covers 300 for making corresponding hinge member 304.As shown in the figure, hinge member 128,130 has opening 128a, a 130a separately, and hinge member 304 can be pressed against wherein to realize being clasped.Once be snapped in appropriate location, protective covers 300 can rotate between an open position and a closed relative to main body 102.When protective covers 300 rotates in open position; protective covers 300 can pulled down (namely; on the direction D in front 104 being parallel to main body 102, as shown in Fig. 3 to Fig. 4) and scratch lower to make protective covers 300 be separated with main body 102 from hinge member 128,130.Should point out, configuration shown in replacing, hinge member 128,130 can have a male form configuration, and hinge member 304 can have a cloudy configuration simultaneously.In addition, less or more hinge member 128,130 and 304 can be set.

For making the main body 102 of a first coupling gear 100a can be connected in the main body 102 of a second coupling gear 100b, first link 132 and second link 134 can be set.In the embodiment shown, the first link 132 and the second link 134 are positioned on the opposition side in front 104 of main body 102.These links 132,134 are designed to be adjoin one another close and guarantee the appropriate alignment in the front 104 of coupling gear 100a, 100b.Correspondingly, when the first coupling gear 100a is directed towards the front 104 of the second coupling gear 100b with its front 104, second link 134 of the first coupling gear 100a engages with first link 132 of the second coupling gear 100b.Equally, second link 134 of the second coupling gear 100b engages with the first link 132 of the first coupling gear.The very eurypalynous link performing joint and alignment function can be used, and does not depart from the concept presented at this.

In example shown embodiment, the first link 132 comprises an extension part 136, and this extension part has the bending major component 136a and multiple side part 136b that form a passage 138 together.This passage 138 limits the internal capacity 140 being wherein provided with a locking latch component 142.As seen best in Figure 25 A, locking latch component 142 has an extension part 142a, an inclined surface 142b and locking surface 142c.Inclined surface 142b (as shown in embodiment directed) is towards the bending major component 136a of extension part 136.

Second link 134 comprise be positioned at front 104 the opposition side extended with the first link on an extension part 144.Extension part 144 has a bending major component 144a and multiple side 144b.The bending major component 144a of the second link 134 is configured in the internal capacity 140 of the passage 138 being received in the first link 132.Two coordinate the appropriate alignment between main body 102 to be by surrounding and guiding the side part 136b of the first link extension part 136 of the side 144b of the second link extension part 144 to be guaranteed.

The extension part 144 of the second link 134 also has a lock bolt engaging surface 144c, for engaging with the locking surface 142c of locking latch component 142, makes two to coordinate main body 102 like this once place to connect state in advance, just inseparable.Correspondingly, when the front 104 of each coupling gear 100a, 100b is pressed toward each other, locking latch component 142 engages latch engaging surface 146 to be fixed together these devices 100a, 100b under pre-connection state.This action also provides a click sound that can hear, so that the instruction providing pre-connection state to realize to user.In this state, the sealing component 200 of each device 100a, 100b with film 400 betwixt and mutual compression is abutted together.

Other arrangements of locking latch component and lock bolt engaging surface are also possible.Such as, lock bolt engaging surface 144c can be arranged on the first link 132, and locking latch component 142 is arranged on the second link 134 simultaneously.Alternately, first coupling gear can be provided with the first substantially similar each other link and the second link, and wherein the second coupling gear is also provided with and is configured to and the first link on the first coupling gear and substantially similar the first link of the second link and the second link.However, it should be understood that disclosed embodiment allows to produce a single main body for these two kinds of coupling gears 100a, 100b.So a kind of configuration can allow that economics of scale is better, stock control is less, system flexibility improves and training request is less.The link except lock bolt can also be used.

With reference to Figure 31 to Figure 34, illustrate in greater detail sealing component 200.In the embodiment shown, sealing component 200 has the length L.sub.2 extended between a first surface 202 and second face 204, and this length is greater than the length L.sub.1 of the recess 116 of main body 102 slightly.The larger lengths of sealing component 200 ensure that fully contacting, to form a sterility sealing of sealing component 200 and a corresponding sealing component 200 in second main body 102.Sealing component 200 also has a central opening 206, and this central opening has an internal diameter D.sub.3, and the size of this internal diameter is approximately identical with the diameter D.sub.2 of tubes connection 108.Sealing component 200 also has a size outer diameter D .sub.4 approximately identical with the diameter D.sub.1 of the recess 116 in main body 102.In one embodiment, outer diameter D .sub.4 is greater than length L.sub.2.In one embodiment, outer diameter D .sub.4 is than length L.sub.2 greatly from about 1.25 times to about 1.75 times, such as, and about 1.5 times.

Sealing component 200 also has a sidewall S, and this sidewall has the thickness of reduction in the midpoint of sidewall S.In outside, sidewall S has the thickness of the reduction limited by an outer radius r.sub.o.In inside, sidewall S has the thickness of the reduction limited by an inside radius r.sub.i.In one embodiment, the size of inside radius r.sub.i is the size being greater than outer radius r.sub.o.In one embodiment, the size of inside radius r.sub.i is the twice of the size being equal to or greater than outer radius r.sub.o, such as, large about 2.4 times.In one embodiment, inside radius r.sub.i is between about 0.2 inch to about 0.3 inch, such as, and about 0.26 inch.In one embodiment, outer radius r.sub.i is between about 0.1 inch to about 0.25 inch, such as, and about 0.11 inch.

When inside radius r.sub.i is greater than outer radius r.sub.o, sealing configuration enhances the axial compression performance (being compressed between the sealing seat 118 on first surface 202 and another sealing component 200 on the second face 204) of sealing component 200, guarantees that the flowing through sealing component 200 can not be restricted because of being not intended to be formed of the protuberance that extends internally under by compression simultaneously.Because inside radius r.sub.i is greater than outer radius r.sub.o, cause sidewall S outwards away from central opening 206 deflection of Sealing 200 for a compressive force on the Sealing in face 202,204 by tending to.Correspondingly, the restriction of the compression of Sealing 200 is not necessarily subject to through the internal flow path of Sealing 200.When inserting a mechanical pick-up device by the central opening 206 of Sealing, such structure is particularly useful.When pressurizeing to system, described sealing configuration also provides the sealing of enhancing.

With reference to Figure 27 to Figure 30, illustrate in greater detail protective covers 300.Protective covers 300 has two major functions.First function be coupling gear 100 be in one do not connect state or be isolated state time, the front 104 of protective film 400, sealing component 200 and main body 102.In order to for above-mentioned purpose, protective covers 300 is positioned in closed position, makes being covered by cover piece 300 at least partially of film 400 like this.Second function is to provide the device for removing film 400 after the first coupling gear 100a and the second coupling gear 100b is placed to pre-connection state.In order to for above-mentioned purpose, protective covers 300 is positioned in open position.In the open position, this part of the main body covered front 104 of film 400 is exposed.

In the embodiment shown, protective covers 300 has the main body 302 extended between a first side 302a and the second side 302b and between an a first end 302c and second end 302d.Main body 302 also limits a first surface 310 and a second surface 312.When protective covers 300 in the closed position middle time, first surface 310 is towards the front 104 of the main body 102 of coupling gear 100.Correspondingly, first surface 310 operates the front 104 of protective film 400, sealing component 200 and main body 102.In addition, when cover piece 300 in the closed position middle time, first surface 310 is compression seal component 200 slightly, and this can alleviate sealing component 200 otherwise the pressure that will be applied on film 400.This confined state of sealing component 200 is the most easily seen in Figure 18 and Figure 20.Figure 19 and Figure 21 illustrates the sealing component 200 be in a kind of more relaxed state, even if film 400 still covers sealing component 200.

The second surface 312 of protective covers 300 is provided to allow the second end 204 of film 400 to be attached in protective covers 300.In one embodiment, second surface 312 is provided with a kind of tackiness agent 148, and this film is attached on this tackiness agent.In one embodiment, tackiness agent 148 can be provided on film 400, and this film can be attached on second surface 312 subsequently.Referring to Fig. 4 A, be about the illustrative arrangements of film 400 relative to second surface 312.In one embodiment, film 400 is thermally welded on second surface 312.Film 400 is fully firmly to the connection of protective covers 300, during with box lunch from front 104 removing films 400 of coupling gear main body 102, film 400 is remained in protective covers 300.This result is realized by upset (rolled over) arrangement of film 400 relative to main body 102 to a great extent.This arrangement allows film 400 to be peeled off from front 104 with less power remarkable compared with the power required by the second end 404 shearing film 400 from protective covers second surface on a direction D.Be also pointed out that can by using special adhesive and/or obtaining a strength difference by the relative surface area of these parts be in fact attached in cover piece 300 and main body 102 handling film.

As previously mentioned, the main body 302 at the second end 302d place is also provided with a hinge member 304, and this hinge member can be received in the hinge member 128,130 of main body 102.At the first end 302c place of main body 302, a handle component 314 is set.Handle component 314 is for operation protection cover piece 300 between an open position and a closed, and is used as a gripping member when the main body 102 pulling protective covers 300 away from coupling gear 100.As shown in the figure, handle component 314 comprises multiple surface characteristics 314a, such as passage or rib, for strengthening user's grasping member component 314 and apply the ability of power on handle component 314.

Each protective covers 300 is also provided with a lock tab 306 and a corresponding recess 308.As previously mentioned, lock tab 306 can be snapped in the recess 126 of coupling gear main body 102 or with this recess and engage.In addition, when two coupling gears 100a, 100b are placed in pre-coupled position and when each protective covers 300 in an open position middle time, lock tab 306 can be snapped in the recess 308 of another protective covers 300, as shown in Fig. 2 to Fig. 4.Protective covers 300 attachment is each other implemented because when in an open position middle time, be substantially in same plane P at the face 302e of the cap body 302 of tab 306 and recess 308 position with main body front 104.Once be in this attachment location, D can pull protective covers 300 by handling portion 314 in downward direction being parallel to one of front 104, so that from main body front 104 removing films 400 of coupling gear 100a, 100b.When film 400 is removed, the second face 204 of sealing component 200 is contacting one another and form the sealing of sterility.In this case, coupling gear 100a, 100b is in connection state now.

Because these protective covers 300 are locked in together, this arrangement ensure that self rolls and departs from a kind of mode that is synchronous or near-synchronous from front 104 by these films 400.But, should point out, if protective covers 300 is not fixed together, also can remove film 400 in a sequential manner, although sterility may suffer damage.

With reference to Figure 38 to Figure 40, an embodiment of the coupling gear 100 comprising an optional visual detector 500 is shown.Optional visual detector 500 is that a vision for providing coupling gear 100a, 100b to join to not yet completely in pre-coupled position indicates.The favourable part of such feature is, operator can confirm: these coupling gears 100a, 100b were appropriate each other connections before removal film 400.

As seen best in Figure 38 and Figure 38 A, visual detector 500 comprises an a First look indicator 500a and second visual detector 500b, and these two visual detectors are arranged on the outer surface of the second connection features 134.As shown in the figure, each visual detector 500 has a height h.sub.1 and width w.sub.1.In one embodiment, height h.sub.1 is between from about 0.1 inch to about 0.2 inch, such as, and about 0.14 inch.In one embodiment, width w.sub.1 is between from about 0.01 inch to about 0.1 inch, such as, and about 0.06 inch.

As the most easily seen in Figure 38 A, each visual detector 500 below can also move a distance x.sub.1 after 106 from main body 102.If visual detector 500 is configured such that it extends to next 106 always, then can be visible from a part for visual detector 500 during an angle views.Like this, contribute to guaranteeing when coupling gear 100a, 100b are placed in pre-coupled position by moving after visual detector 500 from behind 106, even when from an angle views, any part of visual detector 500 is not visible.In one embodiment, distance x.sub.1 is from about 0.01 inch to about 0.1 inch, such as, and about 0.10 inch.

Because in pre-connection state, the second connection features 134 is fully received in the first connection features 132, when coupling gear 100a, 100b are successfully placed to pre-connection state, these visual detectors 500a, 500b can't see completely.But as seen in Figure 39 to Figure 40, when coupling gear 100a, 100b do not engage completely, when even not engaging on an only small distance, indicator 500a, 500b expose.Such as, even when coupling gear 100a, 100b divide open only 0.04 inch time, as the situation in Figure 39 to Figure 40, these visual detectors 500a, 500b easily see.

Referring now to Figure 41, an illustrative methods 1000 for being connected to by sterility coupling gear 100a on sterility coupling gear 100b is shown.

First, at operation 1002 place, provide the second sterility coupling gear 100a that a first sterility coupling gear 100a and substantially similar.In one embodiment, each sterility coupling gear comprises a main body 102 and the first connection features 132 and the second connection features 134 with an internal fluid passageway 110.Also comprise the sealing component 200 be received at least in part in main body 102, just as to be attached in main body 102 and one of covering internal fluid passage 110 can remove film 400.Each sterility coupling gear also comprises rotatably and of being removably attached in main body 102 can remove cover piece 300, and this can be removed cover piece and also be attached to and can remove on film 400.In one embodiment, step 1002 comprises provides the first incomplete same each other sterility coupling gear 100a and the second sterility coupling gear 100b.

Secondly, at operation 1004 place, the protective covers 300 of each sterility coupling gear is moved to an open position.

At operation 1006 place, first sterility coupling gear 100a and the second sterility coupling gear 100b is in alignment with each other under the non-connection state of one and is connected to each other subsequently to form a kind of pre-connection state, such as, connected by multiple connection features 132,134.

At operation 1008 place, protective covers 300 being attached to one another, simultaneously at operation 1010 place, departing from by making protective covers 300 film 400 removing each coupling gear 100a, 100b from coupling gear 100a, 100b.As noted before, the removal of film 400 allows sealing component 200 to adjoin one another conjunction, thus causes the formation of an aseptic connection.Be also pointed out that step 1008 can be excluded and step 1010 can comprise and removes these films one at a time in a kind of mode of order, although sterility may suffer damage.

In the exemplary embodiment, sterility coupling gear and corresponding cover piece thereof are made up of a kind of polymer material.Such as, in one embodiment, sterility coupling gear to be made up of polycarbonate (PC) and wherein used sealing component is made up of a kind of silicone rubber.Other materials can be used.

In certain embodiments, film 400 for sterilizing be autoclavable with Gamma-stable.In various embodiments, a kind of composite design of being made up of two parts (label and an exhaust port) of film 400.This label is a veneer, and this veneer comprises: polyethylene terephthalate (PET) film, polyethylene (PE) foam, aluminium foil and a sealing layer.This foam and/or paper tinsel may reside in or can not be present in final configuration.Sealing layer allows this tag adhesive or is welded on polycarbonate (PC) link (such as, sterility coupling gear 100a and 100b).

This exhaust port is poly-(tetrafluoroethylene) (ePTFE) film that bonded or of being welded on label expanded.When label with exhaust port is bonded or when being welded on link, film 400 is positioned on the center in the stream region of sterility coupling gear 100a and 100b respectively.This exhaust port allows air and steam to flow in sterilization process in system 10.The pore size of film 400 is such, makes film 400 leach the microorganism being greater than 0.2 micron.

In another embodiment, film 400 is a polyether sulfone (PES) and polyester laminated film.This film is hydrophobic and breathable.This pore size is such, and the microorganism being greater than 0.2 micron is filtered off.When boning, polycarbonate melt, in polyester fibre, make PES serve as filter like this, and polyester serves as structure.

In other embodiments, film 400 is a kind of Tyvek films, and this film is applied to allow film 400 to be bonded on polycarbonate (PC) link (such as, sterility coupling gear 100a and 100b) on side.Tyvek is breathable in itself, does not need the exhaust port that extra like this.Tyvek is a kind of non-woven polyethylene film.

Above-described different embodiment provides by means of only illustrational mode and should not be interpreted as limiting following claims.Those of ordinary skill in the art will be easy to recognize, can carry out various improvement and change, and not follow and illustrate and the exemplary embodiment that describes and application at this, and not depart from true spirit and the scope of this disclosure.

Claims

1., for being attached to a first sterility coupling gear on a second sterility coupling gear, this first sterility coupling gear comprises:

A. first main body, this first main part limitation front and the first fluid passage passed wherein;

B. be arranged in first connection features in this main body, this first connection features is constructed such that this first aseptic device is attached on this second sterility coupling gear;

C. first sealing component, this first sealing component is received in this first main body at least partly;

D. a first film, this first film is removably attached to and is covered this front and this first sealing component of this first main body at least in part; And

E. to be removably connected in this main body and first protective covers on this first film, this first protective covers is rotatable between a closed position and an open position, in this closed position, this protective covers covers the main body covered front of this first film at least partially, and this first film covering this front of this main body in this open position is exposed;

F. wherein remove this first protective covers cause this first film to be removed by from this front away from this main body on the direction being parallel to this front.

2. the first sterility coupling gear as claimed in claim 1; wherein this first protective covers and this second protective covers are configured to be attached to one another, and make these films of this first sterility coupling gear and this second sterility coupling gear to be removed from each main body front so simultaneously.

3. the first sterility coupling gear as claimed in claim 1, wherein this first connection features comprises first link and second link, wherein this second link of this first sterility coupling gear can be received in this second sterility coupling gear first link in and wherein second link of this second sterility coupling gear can be received in this first link of this first sterility coupling gear.

4. the first sterility coupling gear as claimed in claim 3, wherein with this second connector element, this first connector element of this first sterility coupling gear and this second sterility coupling gear is constructed such that to align in these fronts of each main body, makes these fronts be parallel to each other like this.

5. the first sterility coupling gear as claimed in claim 1, wherein this first sterility coupling gear and this second sterility coupling gear have a kind of substantially similar structure.

6. the first sterility coupling gear as claimed in claim 1, wherein this first sterility coupling gear and this second sterility coupling gear are provided with a visual detector separately, it is visible that this visual detector is in when one does not connect state at these coupling gears, and when this first connection features of this first coupling gear engages with this second connection features with this corresponding first connection features of this second coupling gear completely with this second connection features, this visual detector be can't see.

7. the first sterility coupling gear as claimed in claim 6, wherein this visual detector be one of this main body of each from this first coupling gear and this second coupling gear below by after move.

8. a sterility connection arranges, and comprising:

A. the first sterility coupling gear as claimed in claim 1; And

B. a second sterility coupling gear, this second sterility coupling gear comprises

I. second main body, this second main part limitation front and the second fluid passage passed wherein;

Ii. be arranged in second connection features in this second main body, this second connection features is configured to engage with this first connection features of this first sterility coupling gear;

Iii. second sealing component, this second sealing component is received in this second main body at least partly;

Iv. second film, this second film is removably attached to and is covered this front and this first sealing component of this second main body at least in part; And

V. to be removably connected in this second main body and second protective covers on this second film, this second protective covers is rotatable to an open position from a closed position, in this closed position, this protective covers covers this second main body front of covering of this first film at least partially, and this second film covering this front of this second main body in this open position is exposed;

Vi. wherein remove this second protective covers cause this second film to be removed by from this front away from this second main body on the direction being parallel to this front.

9. sterility connection as claimed in claim 8 arranges; wherein this first protective covers and this second protective covers are configured to be attached to one another, and make these films of this first sterility coupling gear and this second sterility coupling gear to be removed from each main body front so simultaneously.

10. sterility connection as claimed in claim 8 arranges, wherein this first connection features and this second connection features comprise first link and second link separately, wherein this second link of this first sterility coupling gear can be received in this second sterility coupling gear this first link in and wherein this second link of this second sterility coupling gear can be received in this first link of this first sterility coupling gear.

11. sterility connections as claimed in claim 10 arrange, wherein with this second connector element, this first connector element of this first sterility coupling gear and this second sterility coupling gear is constructed such that to align in these fronts of each main body, makes these fronts be parallel to each other like this.

12. sterility connections as claimed in claim 8 arrange, and wherein this first sterility coupling gear and this second sterility coupling gear have a kind of substantially similar structure.

13. sterility connections as claimed in claim 8 arrange, wherein this first sterility coupling gear and this second sterility coupling gear are provided with a visual detector separately, it is visible that this visual detector is in when one does not connect state at these coupling gears, and when this first connection features of this first coupling gear engages with this second connection features with this corresponding first connection features of this second coupling gear completely with this second connection features, this visual detector be can't see.

14. sterilitys as claimed in claim 13 connections arrange, wherein this visual detector be from one of this main body of each this first coupling gear and this second coupling gear below by after move.

15. 1 kinds of methods for the formation of an aseptic connection, the method comprises:

A. provide the first sterility coupling gear and the second sterility coupling gear, this first sterility coupling gear has the one substantially similar with this second sterility coupling gear and constructs;

B. a protective covers of this first sterility coupling gear is made to rotate to an open position, to expose at least partially film in the front covering this first sterility coupling gear;

C. a protective covers of this second sterility coupling gear is made to rotate to an open position, to expose at least partially film in the front covering this second sterility coupling gear;

D. this first sterility coupling gear is made to be connected on this second sterility coupling gear;

E. this protective covers of this first sterility coupling gear is made to be connected in this protective covers of this second sterility coupling gear; And

F. the protective covers by making these be connected departs to come from this first coupling gear and this second coupling gear on the direction being parallel to these fronts removes film from these fronts of this first coupling gear and this second coupling gear, to provide a sterile fluid path through this first coupling gear and this second coupling gear.

16. methods as claimed in claim 15; comprise further and this first protective covers and this second protective covers are attached to one another, make these films of this first sterility coupling gear and this second sterility coupling gear to be removed from each main body front so simultaneously.

17. methods as claimed in claim 15, wherein this first sterility coupling gear and this second sterility coupling gear are constructed such that these fronts alignment of each main body, make these fronts be parallel to each other like this.

18. methods as claimed in claim 17, wherein this first sterility coupling gear and this second sterility coupling gear have a kind of substantially similar structure.

19. methods as claimed in claim 15, wherein this first sterility coupling gear and this second sterility coupling gear are provided with a visual detector separately, it is visible that this visual detector is in when one does not connect state at these coupling gears, and when this first connection features of this first coupling gear engages with this second connection features with this corresponding first connection features of this second coupling gear completely with this second connection features, this visual detector be can't see.

20. methods as claimed in claim 19, wherein this visual detector be one of this main body of each from this first coupling gear and this second coupling gear below by after move.